Z-0695-2013Class II

Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003

Name: Z-0695-2013 Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003
Creator: Stryker Howmedica Osteonics Corp.
Published: 2012-10-25
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2012-10-25 / Terminated / root cause: design

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003 on 2012-10-25. FDA classified it as Class II and gives the reason as "Two complaints have been filed where Hoffman LRF Wires have broken during load bearing application by patients". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0695-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-25
Posted: 2013-01-17
Terminated: 2015-12-01
Recalling firm: Howmedica Osteonics Corp
Product: Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.
Product code: KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Reason for recall: Two complaints have been filed where Hoffman LRF Wires have broken during load bearing application by patients.
Root cause tag: design
FDA root cause: Device Design
Action: Stryker sent "Urgent Medical Device Removal" notification letters and acknowledgement forms dated 10/25/2012 via Fed Ex to Branches/Agencies with return receipt. Stryker sent notification letters/acknowledgement forms dated 10/26/202 via Fed Ex to Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. The letters described the device issue and provided recommended actions. Questions were directed to Stryker Customer Service.
Quantity in commerce: 476 units
Distribution: Nationwide Distribution, including the states of PA, OH, NY, CA and IL.
Product codes and lots: Catalog number 4933-1-001, Lot number Z02804, Z08348, Z08350, Z12549, Z16753. Catalog number 4933-1-002, Lot number Z08351, Z12554, Z16246, Z16752. Catalog number 4933-1-003 Lot Number Z08349, Z09344, Z12551, Z16996.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0695-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0695-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-23	2013-01-17

Product code KTT

K113327Class IIHoffmann Lrf (Limb Reconstruction Frame) SystemStryker Corp. / cleared 2012-03-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)